Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy For The Treatment of Chronic Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Extracorporeal Shockwave Myocardial Revascularization(ESMR)Therapy For The Treatment of Chronic Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251185
• Other study ID #: ESMR CHF-IL
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2010
• Last updated: February 17, 2013
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Medispec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Evaluation of non-invasive treatment modality, using low-intensity extracorporeal shockwaves for treatment of subjects diagnosed with Congestive Heart Failure, with ischemic etiology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is male or female 18 years or older.

2. Patient is diagnosed with a Heart Failure with ischemic etiology. Diagnosis is based on medical history, complete physical evaluation, and echocardiography.

3. Patient has documented myocardial segments with impaired contractility. Diagnosis is based on Rest Echo.

4. Patient is diagnosed with no more than 50% of segments akinetic or dyskinetic Diagnosis is based on echocardiography.

5. Patient is classified as NYHA II to IV.

6. Patient should be on a stable dosage of medication for at least 6 weeks prior to enrollment.

7. Patients Ejection Fraction < 50%.

8. Patient is stable and without clinical events for > 3 months.

9. Patient has signed an informed consent form.

10. Patient's condition should be stable and should have a life expectancy of >12 months.

11. Patient's current and past medical condition and status will be assessed using previous medical history, physical evaluation, and the physicians (principle investigator's)medical opinion.

Exclusion Criteria:

1. Patient with intraventricular thrombus.

2. Severe COPD (patients with an FEV1 less than .8 liters).

3. Patient has chronic lung disease including emphysema and pulmonary fibrosis.

4. Patient has active endocarditis, myocarditis or pericarditis.

5. Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any ESWT machine for neovascularization of a competitor company within 3 months of entry into the study.

6. Patients who are unwilling or unable to cooperate with study procedure.

7. Patients who are unwilling to quit smoking during the study procedure (including screening phase).

8. Patients who are diagnosed with severe valvular disease (regurgitation or stenosis).

9. Patient is pregnant.

10. Patient with a malignancy in the area of treatment without complete remission within 5 years(lungs, thorax, ribs).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Cardiospec
Non-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9).

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the number of myocardial segments that improve their contractility(at rest and at stress)at 6 months post baseline evaluations, evaluated by echocardiography.	An echo examination shall be used to evaluate myocardial contractility post treatments.	6 months	Yes
Secondary	6 Minutes Walk Test (6MWT)	Evaluation of 6MWT time from baseline to 6 months post baseline.	6 months	No